Manager GQ-CT&S Audits and Inspections

Princeton, NJ, United States
Oct 07, 2019
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Description of the area:

Global Quality (GQ) - Clinical Trials and Safety, GQ-CT&S is responsible for auditing all processes related to clinical research includingspecific medical affairs processes, and pharmacovigilance activities, to assess compliancewith relevant regulations and applicable policies and procedures. This includesinvestigator site, internal systems (e.g. REMS, clinical monitoring), and external clinical trial related vendor audits. Our department is alsoresponsible for management of regulatory agency inspections and for providing advice on regulatory (GCP and GVP) requirements. GQ also offers support as SME during Due Diligence and if areas of serious non-compliance are identified.

Purpose/Objective of the job
  • Conduct Good Clinical Practice (GCP) and pharmacovigilance (PV) audits as above described.
  • Act as project-specific liaison between R&D Quality - CT&S and key stakeholders, includingGlobal Clinical Operations and Global Regulatory, Safety & Biometrics (GRSB) personnel,monitoring the status of the project(s) to plan audits and assuring R&D Quality - CT&S leadership as informed.

Key Responsibilities and Major Duties
  • Perform GCP and PV audits, including audits of clinical investigator sites, vendors, internalsystems and clinical study reports to assess regulatory compliance;
  • Apply audit principles, procedures, and methods; Collect information through effective interviewing, listening, observing and reviewingdocuments, records and data;
  • Prioritize and focus on matters of significance; Confirm the sufficiency and appropriateness of audit evidence to support audit findingsand conclusions;
  • Assess those factors that may affect the reliability of the audit findings and conclusions;
  • Prepare clearly-written, concise, accurate and evidence-based audit report;
  • Review and assess (or support the review) received corrective and preventive action plans according to specifiedtimelines to ensure resolution of audit findings and prevent recurrence.
  • Maintain an in-depth knowledge of governmental regulations impacting clinical researchand PV and development of medicines.
  • Provide advice and counsel concerning GCP regulatory requirements.
  • Collaborate with management in creating and/or reviewing metrics and trend analyses on audits/inspection findings and related CAPAs, for escalation to management and stakeholder
  • Act as project-specific liaison (Project Coordinator) and provide input into audit plans and strategy.
  • Regularly evaluate clinical research processes to determine compliance withregulatory requirements and established standard operating procedures.
  • May provide mentoring for new staff, as needed.
  • Regular collaboration/contact with GCO and GRSB personnelrelated to projects for which the incumbent is Project Coordinator.
  • Possible interactions with external auditors and Regulatory Agency inspectors during the conduct of healthauthority inspections either at clinical sites or at BMS facilities.
  • Miscellaneous contacts as assigned by R&D quality -CT&S management.

Supervisory Responsibility
  • None

Key Stakeholders/Contacts -
  • Regular contact and collaboration with Global Quality CT&S strategy roles, GQ and Clinical Quality governance (risk management and CAPA), colleagues/co-auditors located globally;
  • Contact with appropriate technical, supervisory and management personnel internallyand externally (investigator sites, vendors, etc.) in the conduct and reporting of audits.

List of minimum requirements
  • Degree/Certification/Licensure
    • Bachelor's degree required - Life Sciences degree preferred

  • Experience/Responsibility and minimum # of years:
    • Solid previous experience in clinical trial related roles
    • Demonstrated specifictechnical knowledge of the GCP areas subject to audit, as evidenced by atIeast 4 years in the pharmaceutical industrypreferably in the R&D/clinical trial or equivalent area.
  • Desired minimum 2 years of auditing (GCP auditing is preferred)

  • Competencies/Knowledge/skills
  • Strong skill in risk based prioritization
  • Strong critical thinking to analyze complexsituations and discern critical issues andnon-compliant situations and torecommend appropriate corrective and preventive actions;
  • Good understanding of the drugdevelopment process
    • Demonstrates computer literacy and is ableto function independently within an environment that relied heavily on technology for information and communication
  • Excellent oral and written communication;
  • Fluent in English (and other languages, asapplicable to assigned audit region);
  • Sense of diplomacy and discretion;
  • Maintains the confidentiality and securityof information, data and records;
  • Demonstrates commitment to deliveringhigh-quality work product;
  • Knowledge of governmental regulations impacting clinical research and drug development
  • Understand the appropriateness andconsequences of using sampling techniques
  • for auditing;
  • Ability to make ethical, scientifically soundrecommendations, consistent with company policy/strategy and cost effective;
  • Demonstrates flexibility, open-mindednessand adaptability to a rapidly changing environment;
  • Develops strong working relationships withkey stakeholders;
  • Ability to manage competing priorities.

BMS Behaviors and Working conditions:
  • BMS Biopharma Behaviors required: Passion, Accountability, Innovation,Speed
  • Travel Required (nature and frequency) approximately 25% travel to perform auditsand attend professional meetings andseminars.
  • Overnight Absences Required (pertypical month): Approximately 5 days per month
  • Software that must be usedindependently and without assistance (e.g., Microsoft Suite, Electronic Trial Master File, Oracle clinical database, RAVE, Trackwise, Sharepoint, etc )

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.